Trial Outcomes & Findings for Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents (NCT NCT04625686)
NCT ID: NCT04625686
Last Updated: 2025-01-27
Results Overview
Compare the number of recurrent suicidal event across three treatment groups. Suicidal events were measured by hospitalizations during the study time frame in analysis.
Recruitment status
COMPLETED
Target enrollment
249 participants
Primary outcome timeframe
6 Months
Results posted on
2025-01-27
Participant Flow
Participant milestones
| Measure |
Inpatient Treatment
Inpatient psychiatric treatment
Mental Health Treatment: Treatment of suicidal ideation
|
OCIC Treatment
In-person outpatient crisis intervention
Mental Health Treatment: Treatment of suicidal ideation
|
Telehealth Therapy Treatment
Virtual outpatient therapy
Mental Health Treatment: Treatment of suicidal ideation
|
No Show Group
Participant who do not attend recommended treatment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
87
|
77
|
76
|
9
|
|
Overall Study
COMPLETED
|
82
|
74
|
74
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents
Baseline characteristics by cohort
| Measure |
Inpatient Treatment
n=87 Participants
Inpatient psychiatric treatment
Mental Health Treatment: Treatment of suicidal ideation
|
OCIC Treatment
n=77 Participants
In-person outpatient crisis intervention
Mental Health Treatment: Treatment of suicidal ideation
|
Telehealth Therapy Treatment
n=76 Participants
Virtual outpatient therapy
Mental Health Treatment: Treatment of suicidal ideation
|
No Show Group
n=9 Participants
Participant who do not attend recommended treatment
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
15.2946 years
n=5 Participants
|
14.8463 years
n=7 Participants
|
14.8671 years
n=5 Participants
|
14.9781 years
n=4 Participants
|
15.0467 years
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
60 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Transgender Male (FTM)
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Transgender Female (MTF)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Non-binary
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Choose not to disclose
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
188 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
165 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
CHRT-SR Score
|
38.0114 scores on a scale
n=5 Participants
|
32.0657 scores on a scale
n=7 Participants
|
33.0266 scores on a scale
n=5 Participants
|
36.7777 scores on a scale
n=4 Participants
|
34.2634 scores on a scale
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsCompare the number of recurrent suicidal event across three treatment groups. Suicidal events were measured by hospitalizations during the study time frame in analysis.
Outcome measures
| Measure |
Inpatient Treatment
n=87 Participants
Inpatient psychiatric treatment
Mental Health Treatment: Treatment of suicidal ideation
|
OCIC Treatment
n=77 Participants
In-person outpatient crisis intervention
Mental Health Treatment: Treatment of suicidal ideation
|
Telehealth Therapy Treatment
n=76 Participants
Virtual outpatient therapy
Mental Health Treatment: Treatment of suicidal ideation
|
No Show Group
n=9 Participants
Participant who do not attend recommended treatment
|
|---|---|---|---|---|
|
Number of Recurrent Suicidal Events Measured by Treatment Arm
|
0.66 hospitalizations
Interval 0.33 to 0.98
|
0.45 hospitalizations
Interval 0.21 to 0.69
|
0.20 hospitalizations
Interval 0.08 to 0.31
|
0.60 hospitalizations
Interval -0.08 to 1.28
|
SECONDARY outcome
Timeframe: 6 MonthsThe Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v1.0 - Short Form 4a was used to measure life satisfaction and response pattern scoring was calculated in RedCap.• Each question has five response options (1 to 5), with the total score ranging from 4 to 20, where higher values indicate better life satisfaction.
Outcome measures
| Measure |
Inpatient Treatment
n=87 Participants
Inpatient psychiatric treatment
Mental Health Treatment: Treatment of suicidal ideation
|
OCIC Treatment
n=77 Participants
In-person outpatient crisis intervention
Mental Health Treatment: Treatment of suicidal ideation
|
Telehealth Therapy Treatment
n=76 Participants
Virtual outpatient therapy
Mental Health Treatment: Treatment of suicidal ideation
|
No Show Group
n=9 Participants
Participant who do not attend recommended treatment
|
|---|---|---|---|---|
|
Which Treatment Leads to Better Life Satisfaction
|
15.75 Scores on a scale
Interval 13.49 to 18.02
|
16.74 Scores on a scale
Interval 14.47 to 19.02
|
15.4 Scores on a scale
Interval 13.33 to 17.48
|
14 Scores on a scale
Interval 5.83 to 22.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksThe Client Satisfaction Questionnaire (CSQ), was used to compare the level of treatment satisfaction across three treatment groups. Data collected from children were used in outcome analysis. The four-point Likert scale, with scores from 1 to 4 for each item, provides a total score range of 8 to 32, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Inpatient Treatment
n=87 Participants
Inpatient psychiatric treatment
Mental Health Treatment: Treatment of suicidal ideation
|
OCIC Treatment
n=77 Participants
In-person outpatient crisis intervention
Mental Health Treatment: Treatment of suicidal ideation
|
Telehealth Therapy Treatment
n=76 Participants
Virtual outpatient therapy
Mental Health Treatment: Treatment of suicidal ideation
|
No Show Group
n=9 Participants
Participant who do not attend recommended treatment
|
|---|---|---|---|---|
|
Treatment Satisfaction Scores Measured by Treatment Arm
|
23.06 Scores on a scale
Interval 21.49 to 24.63
|
21.78 Scores on a scale
Interval 20.34 to 23.21
|
20.9 Scores on a scale
Interval 19.4 to 22.4
|
17.62 Scores on a scale
Interval 12.11 to 23.13
|
Adverse Events
Inpatient Treatment
Serious events: 20 serious events
Other events: 12 other events
Deaths: 0 deaths
OCIC Treatment
Serious events: 13 serious events
Other events: 9 other events
Deaths: 0 deaths
Telehealth Therapy Treatment
Serious events: 12 serious events
Other events: 13 other events
Deaths: 0 deaths
No Show Group
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inpatient Treatment
n=87 participants at risk
Inpatient psychiatric treatment
Mental Health Treatment: Treatment of suicidal ideation
|
OCIC Treatment
n=77 participants at risk
In-person outpatient crisis intervention
Mental Health Treatment: Treatment of suicidal ideation
|
Telehealth Therapy Treatment
n=76 participants at risk
Virtual outpatient therapy
Mental Health Treatment: Treatment of suicidal ideation
|
No Show Group
n=9 participants at risk
Participant who do not attend recommended treatment
|
|---|---|---|---|---|
|
Psychiatric disorders
Inpatient psychiatric hospitalization
|
23.0%
20/87 • Number of events 26 • 6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
|
16.9%
13/77 • Number of events 15 • 6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
|
15.8%
12/76 • Number of events 21 • 6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
|
33.3%
3/9 • Number of events 6 • 6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
|
Other adverse events
| Measure |
Inpatient Treatment
n=87 participants at risk
Inpatient psychiatric treatment
Mental Health Treatment: Treatment of suicidal ideation
|
OCIC Treatment
n=77 participants at risk
In-person outpatient crisis intervention
Mental Health Treatment: Treatment of suicidal ideation
|
Telehealth Therapy Treatment
n=76 participants at risk
Virtual outpatient therapy
Mental Health Treatment: Treatment of suicidal ideation
|
No Show Group
n=9 participants at risk
Participant who do not attend recommended treatment
|
|---|---|---|---|---|
|
Psychiatric disorders
Increase in Suicidal Thoughts Resulting in ED Visit or Other Psychiatric Evaluation
|
13.8%
12/87 • Number of events 20 • 6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
|
11.7%
9/77 • Number of events 12 • 6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
|
17.1%
13/76 • Number of events 15 • 6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
|
33.3%
3/9 • Number of events 5 • 6 months
Adverse events were characterized as an increase in suicidal thoughts that resulted in an evaluation in the emergency department, staying overnight in the emergency department, or an emergency visit with a clinician or assessment via phone. Serious adverse events were characterized as an increase in suicidal thoughts that resulted in an inpatient psychiatric hospitalization.
|
Additional Information
Rosalie Hemphill LSW
Cincinnati Children's Hospital Medical Center
Phone: 5044940883
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place